# K223321: Omnia Medical Coupler-C Anterior Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Omnia Medical, LLC
- Decided: Mar 13, 2023 after 133 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K953730 (1995). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143626: inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System, Zimmer Spine, Inc. (2015) Summary page 4.
- K113329: K2M, Pyrenees Cervical Plate System, K2m, Inc. (2012) Summary page 4.
- K183056: ASSURE® Anterior Cervical Plate System, Globus Medical, Inc. (2019) Summary page 4.
- K182489: 4CIS® Pinehurst Anterior Cervical Plate system, Solco Biomedical Co., Ltd. (2019) Summary page 4.

## Indications for use
The Omnia Medical Coupler-C Anterior Cervical Plate is indicated for use in temporarily stabilizing the anterior spine from C2 to T1 during the development of cervical spinal fusion in patients with degenerative disc disease (DDD, neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumors, pseudoarthrosis, or failed previous fusion.

Source page: https://510kreport.com/device/K223321
Methodology: https://510kreport.com/methodology